BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLUNG RAS

    MDR report key: 16200039 · Received January 18, 2023

    Report

    Report Number
    3009763347-2023-00066
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    May 1, 2020
    Report Date
    January 18, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QLN
    UDI-DI
    00850046004179
    PMA / PMN Number
    DEN210006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN (B)(4), FLORIDA. THERE WAS NO REPORT OF PATIENT INJURY. DURING CATHETER PLACEMENT OF AN EUA HEMOLUNG THERAPY, IT WAS REPORTED THAT THE GUIDEWIRE KINKED. THE CATHETER WAS INSERTED OVER THE GUIDEWIRE, BUT THERE WAS DIFFICULTY IN ADVANCING THE CATHETER. THE CATHETER WAS REMOVED AND THE TISSUE WAS DILATED AGAIN. ANOTHER ATTEMPT WAS MADE TO ADVANCE THE CATHETER, BUT WHEN ATTEMPTING TO REMOVE THE WIRE, IT WOULD NOT RETRACT. A WIRE FROM A CENTRAL LINE KIT WAS THEN USED TO CATHETERTE THE VESSEL, AND THEN THE CATHETER AND GUIDEWIRE WERE REMOVED. THE GUIDEWIRE WAS KINKED AND HAD TO BE PULLED THROUGH THE DISTAL END OF THE CATHETER TO REMOVE IT. A GUIDEWIRE FROM A SPARE CATHETER KIT AS WELL AS THE CATHETER ALREADY IN USE WERE USED TO SUCCESSFULLY CATHETERTE THE PATIENT. WHILE THERE WAS STILL DIFFICULTY ADVANCING THE CATHETER DURING THE SUCCESSFUL CATHETER, THE ANGLE OF APPROACH WAS ADJUSTED AND THE CATHETER WAS ABLE TO ADVANCE. THE DATA LOG FROM THERAPY HAS BEEN RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. CONSISTENT BLOOD FLOW AND CO2 REMOVAL WERE OBSERVED IN REVIEW OF THE GRAPHS. THERAPY WAS PROVIDED AS INTENDED. THERE WERE NO CLINICAL COMPLICATIONS REPORTED AS TO HAVE OCCURRED AS A RESULT OF THIS ISSUE. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. GUIDEWIRE KINKING IS A KNOWN POSSIBLE COMPLICATION THAT CAN OCCUR DURING THE CATHETER PROCESS. THERE ARE MANY FACTORS THAT CAN CONTRIBUTE TO THE POSSIBILITY OF EXPERIENCING A GUIDEWIRE KINK. ALUNG TECHNOLOGIES, INC. WILL CONTINUE TO MONITOR ANY ISSUES AS THEY ARE REPORTED. THIS MDR IS BEING FILED IN RESPONSE TO A RETROSPECTIVE VIEW OF ALL ALUNG TECHNOLOGIES, INC. COMPLAINTS, WHICH IDENTIFIED THAT THE REPORTING DECISION FOR THIS COMPLAINT WAS NOT CORRECT. THIS MDR IS BEING FILED RETROSPECTIVELY TO CORRECT THE ERROR IN THE REPORTING DECISION.

    Description of Event or Problem · 0

    ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT WHILE PROVIDING PHONE SUPPORT THE HEMOLUNG CATHETER WAS INSERTED OVER THE GUIDWIRE BUT THERE WAS DIFFICULTY ADVANCING THE CATHETER. THE CATHETER WAS REMOVED AND TISSUE DILATED AGAIN. ANOTHER ATTEMPT WAS MADE TO ADVANCE THE CATHETER. THIS TIME THE CATHETER WAS ADVANCED BUT WHEN ATTEMPTING TO REMOVE THE WIRE IT WOULD NOT RETRACT. A WIRE FROM A CENTRAL LINE KIT WAS THEN USED TO CATHETE THE VESSEL THEN THE CATHETER AND GUIDEWIRE WERE REMOVED. THE GUIDEWIRE WAS KINKED AND HAD TO BE PULLED THROUGH THE DISTAL END OF THE CATHETER TO REMOVE IT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362761 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19 QLN ALUNG TECHNOLOGIES, INC. HL-CA10-00-000 00850046004179

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female